Replacement blood transfusion apparatus



Nov. 3, 1959 v. c. WILSON ETAI- REPLACEMENT BLOOD TRANSFUSION APPARATUS Filed Jan. 8, 1954 INVENTORJ. I o/neg C. 14/175073, Leon IPz'e/far'skl Their Attorney.

United States Patent REPLACEMENT BLOOD TRANSFUSION APPARATUS Volney C. Wilson, Scotia, and Leon T. Piekarski,

' Schenectady, N.Y.

This invention relates to apparatus for the withdrawal and replacement of vascular fluids of living mammals.

More particularly, this invention relates to apparatus which may be used in the performance of a replacement blood transfusion upon a living human, which will minimize the shock effects caused by the infusion of blood at a temperature'below body temperature.

A principal use contemplated for this invention is the replacement of substantially all the incompatible blood of a new-born infant having Rh factor difficulties with compatible blood. It has been estimated that about one infant out of 600 is born with blood having Rh negative characteristics which are antagonistic to the health and, indeed, life of the infant. The symptoms of this disorder may not manifest themselvesv to the attending physician fora matter of hours after birth. Replacement of this incompatible blood as soon as possible is essential since its presence has an extreme and increasingly debilitating efl ect upon the infant and, if untreated, the child will soon, die. Using previously practiced transfusion techniques and conventional equipment, about a 7 percent mortality rate is to be expected, even when the condition is promptly treated. This high rate has resulted, at least in part, from thermal shock inflicted on an already weakened infant by infusion of replacement blood which is at too low a temperature. Inasmuch as usually about a pint of blood is removed and replaced, about /6 to A; of the weight of the infant is affected. This means that if the temperature of the blood entering the infants body is substantially below the temperature of the blood which is being removed, the infant will experience a quite serious thermal shock. Such a thermal shock may well be, and has certainly been in many instances, fatal.

A further problem always presented when handling blood is its tendency to clot when exposed to air and, to a smaller degree, to metals and glass. In exchange transfusion operations, and particularly in replacement blood transfusions performed on infants, the time which elapses during such an operation is critical. Time which is lost during the operation cleaning apparatus which has become wholly or partially inoperative because of clotted blood may well prove to be fatal to the patient.

A still further problem which is encountered in the removal of blood, particularly from new-born infants, is the tendency of the blood vessel from which the blood is being withdrawn to collapse. In replacement transfusions, it is customary to withdraw blood from a newborn infant by inserting a tube of plastic material through the umbilical vein via the ductus venosus into the inferior vena cava. If the pressure at the inlet of the plastic tube is rapidly lowered, the vena cava will collapse and thereby prevent blood from passing into the tube. This tendency of the blood vessel to collapse serves to increase the time required for the operation and consequently endangers the life of the patient.

The apparatus of this invention provides means for the extraction of blood in discrete amounts from a 'pati-' ent and the replacement of blood so withdrawn by new blood in similar discrete amounts. The apparatus further provides means to prevent the infliction of thermal shock upon the patient and permits the operation to be performed without delays caused by clotting of blood on and in the apparatus. The apparatus is also constructed so that blood may be withdrawn at a much higher rate without delays caused by collapse of the blood vessel from which it is being withdrawn due to pressure drop in the vessel.

It is, therefore, a principal object of this invention to provide apparatus useful in replacement blood transfusion operations which will prevent the infliction of thermal shock upon the patient. It isa further object of this invention to provide a unitary apparatus which will facilitate the removal of vascular fluids from a living mammal in discrete amounts, and which is also employable to infuse liquids into said living mammal in similar discrete amounts.

A further object of this invention is the provision of blood-handling apparatus in which the undesirable clotting of blood is minimized.

It is still a further object of this invention to provide blood extraction apparatus which will permit rapid removal of blood from a blood vessel without inducing the collapse ofthe vessel and thereby impeding the withdrawal.

Further objects and advantages of the apparatus of this invention will become apparent during the detailed de-. scription of the apparatus and its mode of operation; which follows.

In order to more clearly disclose and explain the ap-\ paratus, reference will be made to the following figures; of the drawing: 7

Fig. 1 is a semi-schematic illustration of the apparatus applied to the umbilical vein and vena cava of an infant,

Fig. 2 is a detail drawn to a larger scale of part of the apparatus shown in Fig. 1,

a Fig. 3 is anillustration of a modification of part of the apparatus,

Fig. 4 is an illustration of yet another modification of part of the apparatus, and I Fig. 5 is a cross-sectional view taken along line 5-5 of Fig. 4.

Fig. 6 is a fragmentary view showing a modification of the various figures of the drawing.

The invention will be better understood by reference to the various figures of the drawing. Fig. 1 is a semischematic illustration of the apparatus in which reference numeral 10 is applied to a receptacle or tank which is adapted to contain any suitable heat transfer medium, such as water, the surface of which is shown at 11. Any suitable heater 12 is provided which is controlled by any suitable thermostat 13 so that the temperature of the liquid may be maintained at a constant temperature. It is to be noted here that the receptacle or tank 10 is either open at the top, or is provided with at least one access opening of sufiicientsize to accommodate a conventional blood receptacle, as will be more clearly explained later.

A heat exchanger 15 is provided comprising an elongated central tube 16 surrounded by a jacket 17 and having a pair of interiorly threaded bosses 18 and 19 at each end. A pair of hose connection nipples 20 and 21 provides inlet and outlet openings for the heat exchange medium which will be circulated through jacket 17 around tube 16. Flexible hose 25 provides a path for the heat exchange medium to flow from tank 10 through inlet nipple 20, jacket 17, outlet 21, and hose 26 connects Outlet 21 with the inlet port of any suitable fluid pump a 27. The fluid is then pumped from 27 through hose 28 back into tank 10, thereby completing the cycle. Pump 27 is driven by any suitable means, for example, an electric motor, not shown. 1

A conventional three-port plug valve 30 is'attach'ed by means of a'threaded connection to boss 19. .As shown, one port 31 registers with tube 16, while ports 32 and 33 are disposed at angles of 90 and 180, respectively, thereto. Rotatable valve plug 34'is provided with a T- shaped arrangement of communicating ports, as shown. Port 32 of valve 30 is provided with a tube connection and plastic tube 36 which is connected to a conventional blood receptacle 37. Port 33 is threadedly connected to a conventional syringe 40. 1

A conventional three-port plug valve 45, which is substantially the duplicate of valve 30, is threadedly attached to boss 18. One port 46 registers with tube 16, and ports 47 and 48 are disposed at angles of 90 and 180, respectively, thereto. Rotatable valve plug 49 is provided with a T-shaped arrangement of communicating ports, as shown. Port 47 of valve 45 is connected to syringe 50 by means of a threaded joint, as shown. Port 48 is provided with a tube connection 51 to which is attached a tube 55 made of a plastic material, for example, polyethylene. Tube 55 may be provided at its outer end with a formed tip or catheter as illustrated at 56. This tip 56 is adapted to be inserted in the umbilical vein, schematically shown at 60 in the abdomen 63 of an infant. As shown in greater detail in Fig. 2,-this umbilical vein 60 is in direct communication with'the inferior vena cava, as shown at 65. The tip 56 of tube 55 is inserted a sufficient distance through the umbilical vein 60 so that it extends a substantial distance into the vena cava, as illustrated. It will be noted in the embodiment illustrated in Figs. 1 and 2 that tip 56 is bell-mouthed, or is in the form of a truncated cone, having a greater terminal diameter than the body of the tube. A plurality of perforations or openings 67 are provided through the wall of the tube 55 substantially at the junction of the conical section 56 and the cylindrical portion of tube 55.

In the operation of the invention, assume tube 55 to be in place in the infant patients umbilical vein 60 and vena cava 65, as illustrated in Fig. 1. Further assume pump 27 is circulating the heat exchange medium from tank 10, through hose 25, heat exchanger 15, hose 26, through pump 27, through hose 28 and back into tank 10. Also assume that the heat-exchange medium is being held at a constant temperature, for example, about 104 to 105 F. by means of the thermostatically controlled heater 12. Assume valve 49 is in position shown, i.e., connecting ports 47 and 48 while blocking port 46, and that the passage-constituting port 46, tube 16 and port 31 are filled with new or replacement blood. Syringe 50 then withdraws blood from vena cava 65, filling tube 55, port 48, the T-shaped passages in 'valve plug 49 and port 47 with blood from the infant. A discrete amount of blood is withdrawn by means of syringe 50. This amount will usually be of the order of to 'milliliters. At about the same time, a similar amount of replacement blood is withdrawn from bottle 37 through tube 36, port 32, filling the T-shaped passages in the valve plug 34 andthro'ugh port 33 by syringe 40. Value plug 49 is then turned 90 counterclockwise as viewed in Fig. 1, cutting off communication with port 47 and establishing communication between ports 46 and 48. At the same time, valve plug 34 is turned 90 clockwise, establishing communication between ports 31 and 33 and cutting off port 32. The plunger of syringe 40 is then pulled back an additional distance corresponding to about 0.5 to 1.0 milliliter to insure that any air in the system will be withdrawn into syringe 40 and entrapped there. The new blood in syringe 40 is then forced through ports 33, 31, tube 16, ports 46 and 48, tube 55 and tip 56 into the vena cava 65. While this is happening, syringe 50 is disconnected from valve 45, emptied, cleaned, if necesthe outlet of pump sary, and reconnected to the valve. When syringe 40 has been substantially emptied, valve plugs 34 and 49 are returned to the positions shown in Fig. 1 and the syringes 40 and 50 are then simultaneously refilled with blood from bottle 37 and the infant, respectively. These steps are repeated until a sufficient amount of blood, about 500 milliliters, more or less, has been replaced in the infant.

A specific example of a sucessfulreplacement transfusion which has been performed utilized a heat exchanger having a tube 16 made from No. 21 standard hypodermic stainless steel tubing and which was about 6 inches long. The temperature of the heat exchange medium in the tank, actually a water bath, was regulated at a constant 1 04.5 F. The blood was replaced in about'25 or 26 cycles, each cycle exchanging about 20 milliliters of blood. The operation required about an hour and a half to perform, and, most important, the infants temperature varied from198;0 before the operation to 98.4" F. after. In this particular operation, the blood in bottle 37 was about roomtempera'turje or slightly below. While the apparatus will satisfactorily warm and handle relatively cold blood, it may be preferred that the bottle of blood be warmed in the tank 10 before the operation. The bottle of warm blood may then be connectedto tube 36 and insulated in any suitable manner to maintain the blood at a relatively high temperature.

It has been found that the catheter design shown in Figs. 1 and 2 is quite efficient in preventing the collapse of the vena cava while blood is being withdrawn. This is reflected by the fact that 20 milliliters of blood may be withdrawn in about 2 minutes, while with an untipped tube, 'i;e., one which has not been formedand which terminates in a cylindrical end portion with no side wall perforations, the time for withdrawal of a like amount may double or triple.

Other catheter forms which likewise have been found eflicient in this respect are illustrated in Figs. 3, 4 and 5. The embodiment shown in Fig. 3 comprises asymmetrical impervious bulge 70 formed adjacent the terminus 71 of a plastic tube 72. A plurality of perforations 73 and '74 are made through the side wall of the tube 72 at the junctures of the cylindrical sections of thetube and the bulged portion 70. It has also been found that a plurality of such bulges, slightly spaced from each other and separated by shortcylindrical sections, each intersection of cylindrical tube section and bulged portion being provided with perforations, is also efficient. This modification has not been illustrated since it involves an obvious duplication of structure illustrated in Fig. 3;

The embodiment shown in Figs. 4 and 5 comprises a plastic tube 80, the end of which has been formed into a flattened tubular spiral or helical form 81. This .fiat- -tened tubular cross-section may be :better seen in Fig. 5, a cross-section taken along line 55 of Fig. 4. A plurality of pairs of perforations 82 through the side walls of the flattened tube are made substantially across the minor dimension of the tube.

A further modification, shown in Fig. 6, which may be made to the apparatus involves incorporating another three-port plug valve 90, essentially identical to valves 30 and 45, located between port 47 of valve 45 and syringe 50. By select positioning the valve plug, blood may be drawn into syringe 50 from port 47 through the additional valve and then, by repositioning valve plug91, the withdrawn blood may be discharged to the atmosphere through fitting 92 without necessitating the disconnection of tbesyringe from the apparatus.

As is well known, glass and metal tend to promote clottingof blood. It is equally well known that certain coatings may be applied to these materials which will inhibit this action. It is known, for example, that silicones are useful for this purpose. The tubes 36 and 55, being made of a plastic material, such as polyethylene, do not require a silicone coating.

From the foregoing, it is apparent that this invention provides a unitary apparatus which may be used in the performance of a replacement blood transfusion upon a living mammal which prevents thermal shock by heating the infused blood, minimizes the clotting of blood in the apparatus by a protective coating therein, handles the blood without exposing it to the atmosphere, and is constructed to facilitate the removal of blood by the prevention of blood vessel collapse. The specific examples set forth in the disclosure are illustrative of the invention, it being understood that various modifications can be made within the true spirit and scope of our invention.

What we claim as new and desire to secure by Letters Patent of the United States is:

1. Fluid handling apparatus comprising a catheter for insertion into the vein of a living mammal and serving either to withdraw blood from the vein or inject blood into it, a storage source of blood, blood pumping means, conduits connecting the catheter, the pumping means and the storage source, a selectively positionable multiport valve in the conduit leading to the catheter for con- 7 trolling the flow of blood to and from the catheter, and

a heat exchange means associated with said conduits and said valve for regulating the temperature of the blood as it is pumped from the storage source to the catheter.

2. Fluid handling apparatus as defined in claim 1 in which the heat exchange means consists of a tubular member and a chamber for the circulation of fluid in heat exchange relationship with the tubular member, and in which means is provided for causing the fluid to circulate through the chamber in a predetermined path at a predetermined temperature, said last mentioned means including a thermostatically controlled heater so located with respect to said tubular member as to have little direct heating effect upon the blood flowing through said tubular member.

References Cited in the file of this patent UNITED STATES PATENTS 547,047 Thornton et a1. Oct. 1, 1895 766,336 Farrington Aug. 2, 1904 937,292 Eichholtz Oct. 19, 1909 1,167,062 Groshans Jan. 4, 1916 1,173,031 Pruitt Feb. 22, 1916 1,973,351 Meeker Sept. 11, 1934 2,212,706 Cohn et a1 Aug. 27, 1940 2,504,482 Goldman Apr. 18, 1950 2,638,897 Poitras May 19, 1953 2,659,368 Gibbon et al Nov. 17, 1953 FOREIGN PATENTS 34,224 Germany Jan. 16, 1886 444,819 Germany May 25, 1927 663,760 France Apr. 15, 1929 377,732 Great Britain July 25, 1932 852,671 France Nov. 9, 1939 975,851 France Oct. 17, 1950 997,208 France Sept. 12, 1951 

